IZUMIS 500 mg Extended-Release Tablet

Зміст інструкції

1. IZUMIS 500 mg, 750 mg and 1000 mg prolonged-release tablets
   1. What IZUMIS is and what it is used for
   2. What you need to know before taking IZUMIS
   3. How to take IZUMIS
   4. Possible side effects
   5. How to store IZUMIS
   6. Package Contents and Other Information

IZUMIS 500 mg, 750 mg and 1000 mg prolonged-release tablets

Metformin hydrochloride

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful even if the symptoms of the illness are the same as yours.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:
What IZUMIS is and what it is used for

• 2. What you need to know before you take IZUMIS
• 3. How to take IZUMIS
• 4. Possible side effects
• 5. How to store IZUMIS
• 6. Contents of the pack and other information

1. What IZUMIS is and what it is used for

IZUMIS contains the active ingredient metformin hydrochloride and belongs to a group of medicines called
biguanides, used in the treatment of diabetes.
IZUMIS is used in adults for the treatment of type 2 diabetes when changes in diet and exercise alone do not produce adequate blood glucose (blood sugar) control. Insulin is a hormone that allows body tissues to take glucose from the blood and use it for energy or store it for future use. People with type 2 diabetes do not
produce enough insulin in their pancreas or their body does not respond properly to the insulin they
produce. This causes a build-up of glucose in the blood which can cause several serious long-term problems, so it is important you continue to take the medicine, even if you may not have obvious symptoms.
IZUMIS makes the body more sensitive to insulin and helps restore the normal way your body uses
glucose.
IZUMIS prolonged-release tablets are associated with a stable body weight or a modest weight loss. IZUMIS prolonged-release tablets is specially designed to release the medicine slowly
into your body and is therefore different from many other types of tablets containing metformin.

2. What you need to know before taking IZUMIS

Do not take IZUMIS
if you are allergic to metformin hydrochloride or any of the other ingredients of this medicine
(listed in section 6);
if you have liver problems;
if you have severely reduced kidney function;
if you have uncontrolled diabetes associated with, for example, severe hyperglycemia (high blood glucose levels), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see below "Risk of
lactic acidosis") or ketoacidosis. Ketoacidosis is a condition in which substances called "ketone
bodies" accumulate in the blood and can lead to diabetic pre-coma. Symptoms include
stomach pain, rapid and deep breathing, drowsiness and breath with an unusual, fruity odor;

• if you are dehydrated. Dehydration can lead to kidney problems, which can put you at risk of lactic acidosis (see 'Warnings and precautions');
• if you have a severe infection, such as an infection affecting your lung or bronchial system or nephritis. Severe infections can lead to kidney problems, which can put you at risk of lactic acidosis (see 'Warnings and precautions');
• if you have been treated for acute heart problems or have recently had a heart attack or have severe circulatory problems or difficulty breathing. This could lead to a deficiency in oxygen supply to the tissues, which can put you at risk of lactic acidosis (see 'Warnings and precautions').
• if you are a heavy drinker of alcohol;
• if you are under 18 years of age; if you are about to undergo a radiographic procedure with intravascular administration of iodinated contrast agents.

Warnings and precautions
Talk to your doctor or pharmacist before taking IZUMIS.

Risk of lactic acidosis.
IZUMIS can cause a very rare, but very serious side effect called lactic acidosis, in
particular if your kidneys are not working properly. The risk of developing lactic acidosis is also
higher in the presence of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for more information), liver problems and any other
medical condition characterized by a reduced supply of oxygen to a part of the body
(as in the case of serious heart disease). If you have any of the medical conditions described
above, consult your doctor for further instructions.

Stop taking IZUMIS for a short period of time if you have a medical condition that
may be associated with dehydration(significant loss of body fluids) such as severe vomiting, diarrhea,
fever, exposure to heat or if you drink less fluids than usual. Consult your doctor for further instructions.

Stop taking IZUMIS and immediately contact your doctor or the nearest hospital if you experience
any of the symptoms of lactic acidosis, as this condition can lead to coma.
The symptoms of lactic acidosis include:

• vomiting
• abdominal pain
• muscle cramps
• a general feeling of unwellness associated with severe fatigue
• difficulty breathing
• reduced body temperature and slower heart rate. Lactic acidosis is a medical emergency and must be treated in hospital.

If you are to undergo major surgery, you should stop taking IZUMIS during
the surgery and for a certain period of time thereafter. Your doctor will decide when you should
stop and when you should resume treatment with IZUMIS.
During treatment with this medicine, your doctor will check the function of your kidneys at least once
a year or more frequently if you are elderly and/or if kidney function worsens.
During treatment with this medicine, you may find parts of the tablet in your stools. If this
happens, do not worry – this is normal with this type of medicine.
Continue to follow the dietary guidelines given to you by your doctor and make sure you consume
carbohydrates regularly throughout the day.
Metformin may cause a decrease in the absorption of vitamin B12. Monitoring of serum vitamin B12 levels is recommended in patients at risk of developing vitamin
B12 deficiency.
Do not stop taking this medicine without consulting your doctor.

Other medicines and IZUMIS
If you are to be injected with an iodinated contrast agent into the bloodstream, for example to
perform an X-ray, you must stop taking IZUMIS before or at the time of the injection. The
doctor will decide when you should stop and when you should resume treatment with IZUMIS.
Tell your doctor if you are taking, have recently taken or may take any other medicines.
You may need to have your blood glucose and kidney function checked more frequently, or the
doctor may decide to adjust the dose of IZUMIS. It is particularly important to mention the
following:

• Steroids such as prednisolone, mometasone, beclometasone.
• Medicines that increase urine production (diuretics such as furosemide).
• Medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
• Some medicines for treating high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
• Sympathomimetic drugs including adrenaline and dopamine used to treat heart attacks and low blood pressure. Adrenaline is also present in some dental anesthetics.
• Medicines that can change the amount of IZUMIS in the blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

IZUMIS with alcohol
Avoid excessive alcohol consumption during treatment with IZUMIS as this may increase the risk
of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy, ask your doctor
or pharmacist for advice before taking this medicine.

Driving and using machines
IZUMIS taken alone does not cause hypoglycemia (low blood sugar) and therefore should not
affect your ability to drive or operate machinery.
However, it is important to know that IZUMIS taken with other antidiabetic drugs may cause hypoglycemia,
so in this case you need to be particularly careful when driving or using machinery.

IZUMIS contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dosage unit, which means it is
essentially "sodium-free".

3. How to take IZUMIS

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor
or pharmacist.
Your doctor may prescribe IZUMIS to be taken alone or in combination with other oral antidiabetic drugs or insulin.
Swallow the tablets whole with a glass of water, do not chew them.
Normally you should take the tablets once a day, during the evening meal.
In some cases, your doctor may advise you to take the tablets twice a day. Always take them
with food.

Recommended dose
Generally you will start treatment with 500 mg of IZUMIS per day. After about 2 weeks from the start of
treatment, your doctor may check your blood sugar level and adjust the dose. The maximum
daily dose is 2000 mg of IZUMIS.
If you have reduced kidney function, your doctor may prescribe a lower dose.

If you take more IZUMIS than you should
If you accidentally take more tablets, there is no need to worry. However, if
you experience unusual symptoms, contact your doctor. If the overdose is significant, it is more likely
that lactic acidosis will occur. The symptoms of lactic acidosis are non-specific, such as vomiting, abdominal
pain with muscle cramps, a general feeling of unwellness with severe fatigue and difficulty
breathing. Other symptoms are a reduction in body temperature and heart rate. If you should
experience any of these symptoms, seek immediate medical attention, as lactic acidosis can
lead to coma. Immediately stop taking IZUMIS and contact your doctor or the nearest emergency room
immediately.
If you have taken an excessive dose of the medicine or if a child has accidentally ingested this
medicine, contact a doctor, hospital or Poison Control Center in any case to assess the risks and receive
further instructions.

If you forget to take IZUMIS
Take it as soon as you remember, with food. Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
IZUMIS can cause a very rare but very serious side effect called lactic acidosis (see
section "Warnings and precautions"). If this happens, you must stop taking IZUMIS and
seek immediate medical attention or go to the nearest emergency room, as lactic acidosis can
lead to coma.
IZUMIS may cause abnormalities in liver function tests and hepatitis (inflammation of the liver) which
can cause jaundice. If you develop yellowing of the eyes and/or skin, contact your doctor immediately.
Other possible side effects are listed according to their frequency as follows

Very common(may affect more than 1 in 10 people)
diarrhoea, nausea, vomiting, stomach pain or loss of appetite. If you experience these symptoms,
do not stop taking the tablets, as they usually disappear within about 2 weeks.
Taking the tablets with a meal or immediately afterwards may help.

Common(may affect more than 1 in 100 people)

• taste alterations
• low levels of vitamin B12

Very rare(may affect up to 1 in 10,000 people)

• Skin rashes including redness, itching and hives

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store IZUMIS

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date which is stated on the blister and the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What IZUMIS contains
What IZUMIS 500 mg prolonged-release tablets contain

• The active ingredient is metformin hydrochloride. Each prolonged-release tablet contains 500 mg of metformin hydrochloride (corresponding to 390 mg of metformin base).
• The other ingredients are: sodium carboxymethylcellulose, hypromellose 100,000cP, hypromellose 5cP, microcrystalline cellulose, magnesium stearate.

What IZUMIS 750 mg prolonged-release tablets contain

• The active ingredient is metformin hydrochloride. Each prolonged-release tablet contains 750 mg of metformin hydrochloride (corresponding to 585 mg of metformin base).
• The other ingredients are: sodium carboxymethylcellulose, hypromellose 100,000cP, magnesium stearate.

What IZUMIS 1000 mg prolonged-release tablets contain

• The active ingredient is metformin hydrochloride. Each prolonged-release tablet contains 1000 mg of metformin hydrochloride (corresponding to 780 mg of metformin base).
• The other ingredients are: sodium carboxymethylcellulose, hypromellose 100,000cP, magnesium stearate.

Description of the appearance of IZUMIS and package contents
The 500 mg prolonged-release tablets are white to off-white tablets,
approximately 19 x 9.2 mm in size, capsule-shaped, uncoated, with the number '500' imprinted on one side
and smooth on the other side.
The 750 mg prolonged-release tablets are white to off-white tablets,
approximately 19 x 9.2 mm in size, capsule-shaped, uncoated, with the number '750' imprinted on one side
and smooth on the other side.
The 1000 mg prolonged-release tablets are white to off-white tablets,
approximately 22 x 10.5 mm in size, capsule-shaped, uncoated, with the number '1000' imprinted on one
side and smooth on the other side.

Marketing Authorisation Holder
Farmaceutici Caber S.r.l. - Via del Mare, 36 – Pomezia (RM) – Italy

Manufacturer
Savio Industrial S.r.l., Via Emilia, 21 – Pavia

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Estonia: PREMET
Poland: IRUKA
Italy: IZUMIS